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The trial is taking place at:
U

United Medical Research Institute | Inglewood, CA

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Next Generation Rocklatan

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Alcon

Status and phase

Begins enrollment in 1 month
Phase 2

Conditions

Open Angle Glaucoma
Ocular Hypertension

Treatments

Drug: AR-17043 Ophthalmic Solution
Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution
Drug: PG043 Ophthalmic Solution
Drug: Latanoprost 0.005% Ophthalmic Solution
Drug: Netarsudil 0.02% Ophthalmic Solution
Drug: AR-17043 Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT06441643
GLR305-E001

Details and patient eligibility

About

The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Full description

During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.

During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Stage 1 Key Inclusion Criteria;

  • Diagnosis of OAG or OHT in both eyes.
  • High unmedicated IOP measurements in the study eye as specified in the protocol.
  • Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.
  • Other protocol-specified inclusion criteria may apply.

Stage 2 Key Inclusion Criteria:

  • Diagnosis of OAG or OHT in both eyes.
  • High unmedicated IOP measurements in the study eye as specified in the protocol.
  • Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
  • Other protocol-specified inclusion criteria may apply.

Stage 1 and Stage 2 Key Exclusion Criteria:

  • Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
  • Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
  • Glaucoma other than OAG.
  • Previous glaucoma surgery.
  • Any abnormality preventing reliable measurements.
  • Unable to demonstrate proper eyedrop instillation.
  • Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

450 participants in 10 patient groups, including a placebo group

AR-17043 low concentration (Stage 1)
Experimental group
Description:
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Treatment:
Drug: AR-17043 Ophthalmic Solution
AR-17043 medium concentration (Stage 1)
Experimental group
Description:
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Treatment:
Drug: AR-17043 Ophthalmic Solution
AR-17043 high concentration (Stage 1)
Experimental group
Description:
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Treatment:
Drug: AR-17043 Ophthalmic Solution
AR-17043 vehicle (Stage 1)
Placebo Comparator group
Description:
AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Treatment:
Drug: AR-17043 Vehicle
Rhopressa (Stage 1)
Active Comparator group
Description:
Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Treatment:
Drug: Netarsudil 0.02% Ophthalmic Solution
PG043 low concentration (Stage 2)
Experimental group
Description:
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Treatment:
Drug: PG043 Ophthalmic Solution
PG043 high concentration (Stage 2)
Experimental group
Description:
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Treatment:
Drug: PG043 Ophthalmic Solution
AR-17043 high concentration (Stage 2)
Active Comparator group
Description:
AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Treatment:
Drug: AR-17043 Ophthalmic Solution
Latanoprost (Stage 2)
Active Comparator group
Description:
Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Treatment:
Drug: Latanoprost 0.005% Ophthalmic Solution
Rocklatan (Stage 2)
Active Comparator group
Description:
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Treatment:
Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

Trial contacts and locations

7

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Central trial contact

Alcon Call Center

Data sourced from clinicaltrials.gov

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